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A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms (CIAP-2)

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ClinicalTrials.gov Identifier: NCT03133624
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology of the People's Repubic of China
Information provided by (Responsible Party):
Xinjian Yang, MD, Beijing Neurosurgical Institute

Brief Summary:
This is a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms in China.

Condition or disease
Intracranial Aneurysm

Detailed Description:
This subsequent program China Intracranial Aneurysm Project - 2 (CIAP-2) will comprise screening of 500 patients from the UIA cohort (CIAP-1) and focus on hemodynamics factors, high resolution magnetic resonance imaging (HRMRI), genetic factors and biomarkers. Possible risk factors for rupture of UIA, including genetic factors, biomarkers, HRMRI, and hemodynamic will be analyzed. The first project of the China Intracranial Aneurysm Project (CIAP-1: Chaired by the Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China) will establish a prospective cohort of 5000 patients with UIA from 20 centers in China, and collect baseline information for each patient. Multidimensional data will be acquired in follow-up assessments. Statistically significant clinical features in the UIA cohort will also be analyzed and integrated into this model for predicting risk of UIA rupture. After the model has been set up, the resultant evidence-based prediction will be used to provide a preliminary theoretical basis for the treatment of aneurysms at high risk of rupture.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: This is a Registry Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms in China
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The rupture of intracranial aneurysms [ Time Frame: Up to 12 months or time of aneurysm repair surgery ]
    The rupture of unruptured intracranial aneurysms.


Secondary Outcome Measures :
  1. Changes in morphology of unruptured intracranial aneurysms [ Time Frame: Up to 12 months or time of aneurysm repair surgery ]
    Maximum diameter increase ≥ 1mm or appearance of a daughter sac.


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with at least 1 UIA that is untreated and confirmed by imaging (CTA, MRA and DSA), regardless of the presence of clinical symptoms.
Criteria

Inclusion Criteria:

  • At least 1 UIA that is untreated and confirmed by imaging: Computed tomography angiography (CTA), magnetic resonance angiography (MRA) and digital subtraction angiography (DSA). Regardless of the presence of clinical symptoms
  • Patient currently has the ability to live independently, and a modified Ranking Score less than or equal to 3 points
  • Older than 14 years of age
  • Patient or relatives agreed to sign the consent form

Exclusion Criteria:

  • Subarachnoid hemorrhage of unknown origin
  • Presence of other intracranial vascular malformations, such as cerebral arteriovenous malformation (AVM) or cerebral arteriovenous fistula (AVF)
  • Intracranial and other malignant tumors
  • Fusiform, traumatic, bacterial or dissecting aneurysm
  • Patients with severe mental illness who are unable to communicate
  • Patients with other diseases or poor general condition who are expected to survive less than 1 year
  • Patients with intracranial aneurysms who have joined other similar research institutions
  • Patients who refused follow-up

The definition of modified Ranking Score:

  • 0 Completely silent
  • 1 Despite symptoms, but not visibly disabled, can complete all regular duties and activities
  • 2 Mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
  • 3 Moderate disability requires some help, but walking does not need assistance;
  • 4 Severe disabilities, unable to walk independently, no others can not meet their needs
  • 5 Severely disabled, bedridden, Urine, requiring continuous care and care;
  • 6 Mortality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133624


Contacts
Contact: Jian Liu, MD +86-010-67098852 jianliu_ns@163.com
Contact: Junfan Chen, MS +86-010-67098852 junfan-chen@foxmail.com

Locations
China, Beijing
XuanWu Hospital,Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100053
Contact: Peng Hu, MD    +86-13811385341    doctor_hupeng@163.com   
Principal Investigator: Hongqi Zhang, MD         
China, Chongqing
The 1st Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
Contact: Zongduo Guo, MD    +86-13594118695    stonegzd@163.com   
Principal Investigator: Xiaochuan Sun, MD         
China, Fujian
Zhongshan Hospital Xiamen University Not yet recruiting
Xiamen, Fujian, China, 361000
Contact: Junlong Kang, MS    +86-15960256931    kjl295@163.com   
Principal Investigator: Xinhua Tian, MD         
China, Guangdong
Southern Medical University, Zhujiang Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510282
Contact: Xin Zhang, MD    +86-15989058895    zhangxin19830818@163.com   
Principal Investigator: Chuanzhi Duan, MD         
China, Hunan
The Second Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China, 410011
Contact: Mingming Zhang, MD    +86-13907483144    zmm-zh@163.com   
Principal Investigator: Yugang Jiang, MD         
China, Jiangsu
The First Affiliated Hospital of Soochow University Not yet recruiting
Suzhou, Jiangsu, China, 215006
Contact: Wanchun You, MD    +86-18550038323    wcyou@suda.edu.cn   
Principal Investigator: Zhong Wang, MD         
China, Shandong
Liao Cheng People's Hospital Not yet recruiting
Liaocheng, Shandong, China, 252004
Contact: Qingke Cui, MS    +86-1378718865    45587746@qq.com   
Principal Investigator: Jiyue Wang, MS         
China, Shanghai
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200127
Contact: Shenghao Ding, MD    +86-13817282259    ding_sheng_hao@126.com   
Principal Investigator: Jieqing Wan, MD         
China, Shanxi
Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University Xi'an, China Not yet recruiting
Xi'an, Shanxi, China, 710038
Contact: Wei Guo, MD    +86-18729985168    18729985168@163.com   
Principal Investigator: Yan Qu, MD         
China, Sichuan
West China Hospital of Sichuan University Not yet recruiting
Chengdu, Sichuan, China, 610041
Contact: Zhiyong Liu, MD    +86-13658021726    doctor_lzy@163.com   
Principal Investigator: Min He, MD         
China, Xinjiang
The First Affiliated Hospital Of Xinjiang Medical University Not yet recruiting
Wulumuqi, Xinjiang, China, 830000
Contact: Kahriman Kadeer, MS    +86-18599088599    KAHriman@vip.qq.com   
Principal Investigator: Maimaitili Aisha, MS         
China
Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University Recruiting
Beijing, China, 100050
Contact: Xinjian Yang, MD    +86-010-67098852    yangxinjian@bjttyy.org   
Contact: Jian Liu, MD    +86-010-67098852    jianliu_ns@163.com   
Principal Investigator: Xinjian Yang, MD         
Sponsors and Collaborators
Beijing Neurosurgical Institute
Ministry of Science and Technology of the People's Repubic of China
Investigators
Principal Investigator: Xinjian Yang, MD Beijing Neurosurgical Institute and Beijing Tiantan Hospital affiliated to Capital Medical University,China

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xinjian Yang, MD, Vice Chair of Department of Interventional Neuroradiology of Beijing Neurosurgical Institute, Beijing Neurosurgical Institute
ClinicalTrials.gov Identifier: NCT03133624     History of Changes
Other Study ID Numbers: 2016YFC1300802
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we can share the original data 5 years after the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xinjian Yang, MD, Beijing Neurosurgical Institute:
multi dimensional prediction model
unruptured intracranial aneurysms
rupture risk
computational fluid dynamic
high resolution magnetic resonance images
gene
clinical features
risk factors
registry study
china
biomarkers

Additional relevant MeSH terms:
Aneurysm
Rupture
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases